Clearance Summary
EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) received FDA 510(k) clearance under submission number K251366, sponsored by Nihon Kohden Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2025-10-09.
- Submission: K251366
- Applicant / Sponsor: Nihon Kohden Corporation
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2025-10-09
Classification & Regulation
This clearance is catalogued under FDA product code OLT and 21 CFR 882.1400, within the Neurology review panel as a Class II device.